This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to continue serving as the Scientific and Data Coordinating Center (SDCC) for the Chronic Renal Insufficiency Cohort (CRIC) Study. Chronic renal insufficiency (CRI) affects over 10 million Americans. Their burden of morbidity derives from their frequent progression to end-stage renal disease (ESRD) and disproportionate risk of cardiovascular events. A shared set of etiological factors is being identified as potentially responsible for both progressive renal disease and cardiovascular disease (CVD) including clinical and biomarkers. Characterizing relationships between these risk factors and outcomes will permit development of instruments to predict poor outcomes in patients with CRI and enhance understanding of etiological mechanisms leading to these outcomes. Between 2001-2007, the Prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled >3600 adults with chronic kidney disease to address overarching goals of identifying predictors of rapid progression of kidney disease and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events, death, and resource utilization through an initial 5-year follow-up. Under the leadership of investigators at Penn, subject recruitment and retention have exceeded goals and the quality of data has been outstanding. In addition, the CRIC Ancillary Studies Program has been remarkably successful in expanding the scientific scope of CRIC through 23 funded federal awards. The proposed Phase 2 of CRIC, which extends follow-up through 2013, offers a unique opportunity to leverage the existing effort and success of CRIC to establish a cohort of participants with chronic kidney disease who have long-term prospective follow-up on progression of kidney disease and a variety of outcomes including post-end-stage renal disease health status. This unparalleled resource will expand the science related to chronic kidney disease natural history as well as the impact on cardiovascular disease and other adverse events. The overarching specific aims of the CRICSDCC in Phase II include: 1) set and promote a Chronic Kidney Disease Research Agenda, 2) lead the conduct of all aspects of CRIC Phase II, 3) develop processes to promote randomized, controlled trials in CKD, and 4) facilitate interactions with other clinical studies to promote collaborative CRI research.
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